MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ENDOTAK RELIANCE SG; IMPLANTABLE LEAD

Model Number	0181
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	Calcium Deposits/Calcification (1758)
Date of Event	05/28/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This product is being evaluated in our post market quality assurance laboratory.This report will be updated when evaluation is complete.
Event or Problem Description
It was reported that this right ventricular (rv) lead exhibited a gradual increase in shock impedance measurements.A revision procedure was performed where this rv lead was explanted.Once the lead was removed, upon visual inspection, the shocking coil was observed to have dense calcification on the entirety of the shock coil.A new lead was implanted successfully.No additional adverse patient effects were reported.This rv lead was returned to facility awaiting analysis.

• Brand Name: ENDOTAK RELIANCE SG
• Common Device Name: IMPLANTABLE LEAD
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; road 698, lot no. 12; dorado PR 00646 -260; * 00646-2602
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 25616104
• Report Number: 2124215-2026-33775
• Device Sequence Number: 10194597
• Product Code: LWS
• UDI-Device Identifier: 00802526531156
• UDI-Public: (01)00802526531156(17)201127
• Combination Product (Y/N): Y
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P910073
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/24/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 11/27/2020
• Device Model Number: 0181
• Device Catalogue Number: 0181
• Device Lot Number: 337812
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2026
• Initial Report FDA Received Date: 06/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/27/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 45 YR
• Patient Sex: Male